BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.5CM ADULT CRANI ATTACHMENT

    MDR report key: 3962864 · Received June 13, 2014

    Report

    Report Number
    1045834-2013-16465
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    November 21, 2011
    Report Date
    November 21, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE DEVICE WAS EVALUATED AND THE ISSUE OF CANNOT INSERT CUTTER WAS FOUND. THE DEVICE FAILED PRE-REPAIR DIAGNOSTIC ASSESSMENT CUTTER INSERTION VERIFICATION. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT SERVICE WAS REQUIRED FOR THE DEVICE. DURING SERVICE, THE ISSUE OF CANNOT INSERT CUTTER WAS FOUND. IT IS UNKNOWN IF THE DEVICE WAS BEING USED DURING SURGERY. IT IS UNKNOWN IF INJURY OR MEDICAL INTERVENTION OCCURRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350825 6.5CM ADULT CRANI ATTACHMENT CRANIOTOME HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1